Pharmaceutical emulsions.

They may also be used as solubilizing agents for a variety of substances including essential oils and oil-soluble vitamins, and as wetting agents in the formulation of oral and potential suspensions. They have been found to be useful in improving the oral bioavailability of molecules that are substrates for pglycoprotein1 7. Description: Polysorbates have a characteristic odor and a warm, somewhat bitter taste. Their colors and physical forms at 25C although it should be noted that the absolute color intensity of the products may vary from batch to batch and form manufacturer to manufacturer. 8. Typical Properties: Acidity/alkalinity: PH = 6.0-8.0 for 5%w/v aqueous solution. Flash point: 149C 9. Stability and Storage Conditions: Polysorbates are stable to electrolytes and weak acids and bases; gradual specification occurs with strong acids and bases. The oleic acid esters are sensitive to oxidation. Polysorbates are hygroscopic and should be examined for water content prior to use and dried if necessary. Also, in common with other polyoxyethylene surfactants, prolonged storage can lead to the formation of peroxides. Polysorbates should be stored in a well-closed container, protected from light, in a cool, dry place. 10. Incompatibilities: Discoloration and/or precipitation occur with various substances, especially phenols, tannins, tars, and tarlike materials. The antimicrobial activity of paraben preservatives is reduced in the presence of Polysorbates. 11. Safety: Polysorbates are widely used in cosmetics food products, and oral, parentereal, and topical pharmaceutical formulations and are generally regarded as nontoxic and nonirritant materials. Ther have, however, been occasional reports of hypersensitivity to Polysorbates following their topical and intermuscular use.3 polysorbates have also been associated with serious adverse effects, including some deaths, in low-birthweight infants intravenously administered a vitamin E preparation containing a mixture of Polysorbates 20 and 80. when heated decomposition, the poplysorbates emit acrid smoke and irritating fumes. 12. The WHO has set an estimated acceptable daily intake for Polysorbates 20, 40,, 60, 65, and 80, calculated as total polysorbate esters, at up to 25 mg/kg body- weight. 6 5.4 SORBTAN ESTER 52,54,56, (span 80) 1. Nonproprietary Names: BP: Sorbitan laurate Ph EUR: Sorbitani lauras USPNF: Sorbitan monoaurate (sorbitan, esters monodecanoate) Sorbitan monooleate. 2. Synonyms: Ablunol S- 80, Arlacel 80, Span 80. 3. Chemical Names and CAS Registry Numbers: (Z) Sorbitan mono-9-octadecenoate [1338-43-8]. 4. Empirical Formula and Molecular Weight: C24H44O6, 429 5. Structural Formula:

R1= R2 = OH, R3 = R (see below) for sorbitan monoesters R1 = OH, R2 = R3 = R for sorbitan diesters R1 = R2 = R3 = R for sorbitan trimesters

Density: 1.01 Flash point:> 149C HLB value: 4.3 Hydroxyl value: 193-209 Saponification value: 149-160 Solubility: sorbitan esters are generally soluble or dispersible in oils; they are also soluble in most organic solvents. In water, although insoluble, they are generally dispersible. Surface tension: 30 Viscosity (dynamic): 970-1080 10. Stability and Storage Conditions Gradual soap formation occurs with strong acids or bases; sorbitan esters are stable in weak acids or based. Sorbitan esters should stored in a well-closed container in a cool, dry place. Sorbitan esters are widely used in cosmetics, food products, and oral and topical pharmaceutical formulations and are genereally regarded as nontoxic and nonirritant materials. However, there have been occasional reports of hypersensitive skin reactions following the topical application of products containing sorbitan esters. When heated to decomposition, the sorbitan esters emit acrid smoke and irritating fumes. The WHO has set an estimated acceptable daily intake of sorbitan monopalmitate, monostereate , and tristearate, and of sorbitan monolaurate and monooleate at up to 25 mg/kg body-weight calculated as total sorbitan esters.

5.5. ALCOHOL107,31,92 1. Nonproprietary Names: BP: Ethanol (96%) JP: Ethanol Ph Eur: Ethanolum (96 per centum) USP: Alcohol 2. Synonyms: Ethyl alcohol; ethyl hydroxide; grain alcohol; methyl carbinol. 3. Chemical Name and CAS Registry Number: Ethanol [64-17-5] 4. Empirical Formula and Molecular Weight: C2H6O46.07 5. Structural Formula: 6. Functional Category: Antimicrobial preservative; disinfectant; skin penetrant; solvent.7. Applications in Pharmaceutical Formulation or Technology: Ethanol and aqueous ethanol solutions of various concentrations are widely used in pharmaceutical formulations and cosmetics. Although ethanol is primarily used as a solvent, it is also employed in solutions as an antimicrobial preservative. Topical ethanol solutions are also used as penetration enhancers and as disinfectants. Ethanol has also been used in transdermal preparations in combination with Labrasol as a co- surfactant. 8. Description: In the BP 2004, the term ethanol used without other qualification refers to ethanol containing > 99.5% v/v of C2H6O. the term alcohol, without other qualification, refers ethanol 95.1-96.9% v/v. where other strengths are intended, the term alcohol or ethanol is used, followed by the statement of the strength.